Ipilimumab received a Black Box Warning related to the risk of severe immune reactions that can cause inflammation and severe complications of liver, skin, nervous, intestines, hormone glands and eyes.
Black Box Warnings are given for prescription drugs that may cause severe adverse effects. It is intended to help doctors and patients discuss the risks.
The risks of ipilimumab are well documented, and consistent with cancer immunotherapy and auto immune reactions. The severity of metastatic melanoma often warrants risks where a less fatal disease would not.